Puncture needle

Abstract

The puncture needle can include an elongated portion, a puncture member associated with a distal end of the elongated portion, and a spacer associated with the distal portion of the elongated portion, wherein the spacer is configured to contact a wall of a lumen of a delivery catheter to prevent contact between the puncture member and the wall. The puncture needle can include an elongated portion and a puncture member associated with a distal end of the elongated portion, wherein the puncture member includes a blade edge on a distal edge, and wherein the puncture member is configured to be advanceable through a lumen of a delivery catheter without the blade edge catching on a wall of the lumen.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 890,528 entitled “PUNCTURE NEEDLES”, filed August 22, 2019, the disclosure of which is hereby incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] This disclosure generally relates to the field of transcatheter delivery of medical implant devices and / or therapies. Background Technology

[0004] A puncture needle can be used via a minimally invasive transcatheter approach to deliver medical implants and / or therapies to a target tissue site. Creating openings in tissues containing internal blood vessels, channels, organs, and / or cavities to allow delivery of medical implants and / or therapies may require a puncture needle to be delivered via a catheter to the target tissue site. Summary of the Invention

[0005] This document describes one or more devices, systems, and methods relating to puncture needles used in minimally invasive transcatheter approaches, wherein the puncture needle can be advanced through the lumen of a delivery catheter without becoming stuck, including through one or more bends in the lumen of the delivery catheter.

[0006] For the purpose of summarizing this disclosure, certain aspects, advantages, and novel features are described herein. It should be understood that not all of these advantages can necessarily be achieved according to any particular embodiment. Therefore, the disclosed embodiments may be implemented in a manner that achieves or optimizes one or more advantages as taught herein without necessarily achieving other advantages as taught or implied herein.

[0007] In some embodiments, the puncture system may include a puncture needle configured to be slidably advanced through a delivery catheter lumen. The puncture needle includes an elongated portion and a puncture member associated with the distal end of the elongated portion, the puncture member being configured to puncture tissue. A spacer may be associated with the distal portion of the elongated portion, wherein the spacer may be configured to contact the wall of the delivery catheter lumen to prevent contact between the puncture member and the wall as the puncture member is advanced through bends in the delivery catheter lumen.

[0008] In some embodiments, the spacer includes a predetermined lateral dimension and a predetermined longitudinal dimension, which is configured to prevent contact between the distal end of the puncture member and the wall.

[0009] In some embodiments, the spacer includes a distal end, a proximal end, and a transverse surface between the distal and proximal ends, wherein the transverse surface is spaced a predetermined transverse distance from the distal portion of the elongated portion, and at least one of the transverse surface and the distal end is configured to contact the wall of the delivery catheter lumen to prevent contact between the distal end of the puncture member and the wall.

[0010] In some embodiments, the lateral surface includes a concave, curved surface configured to contact the wall of the delivery catheter lumen. In some embodiments, the lateral surface includes a convex, curved surface configured to contact the wall of the delivery catheter lumen. In some embodiments, the lateral surface includes a surface parallel to the longitudinal axis of the puncture needle, said surface configured to contact the wall of the delivery catheter lumen.

[0011] In some embodiments, the longitudinal cross-section of the spacer includes at least one of a circular segment, an elliptical segment, and a teardrop-shaped segment, wherein the plane along which the longitudinal cross-section extends laterally from the distal portion of the elongated portion along the longitudinal axis of the puncture needle.

[0012] In some embodiments, the spacer is symmetrical about an axis collinear with the longitudinal axis of the puncture needle. In other embodiments, the spacer is asymmetrical about an axis collinear with the longitudinal axis of the puncture needle.

[0013] In some embodiments, the spacer extends circumferentially around the distal portion of the elongated portion. In some embodiments, the spacer is positioned circumferentially around the distal portion of the elongated portion.

[0014] In some embodiments, the spacer includes a ring shape. In some embodiments, the transverse surface of the ring includes a concave curvature. In some embodiments, the transverse surface of the ring includes a convex curvature. In some embodiments, the transverse surface of the ring is parallel to an axis collinear with the longitudinal axis of the puncture needle.

[0015] In some embodiments, the spacer includes a plurality of distinct portions positioned around the distal portion of the elongated portion. In some embodiments, the spacer includes a plurality of lobes positioned circumferentially around the distal portion. In some embodiments, the spacer includes a plurality of panels extending circumferentially around the distal portion of the elongated portion.

[0016] In some embodiments, the spacer is adjacent to the puncture member. In some embodiments, the spacer is located at a predetermined distance proximal to the puncture member.

[0017] In some embodiments, a method of puncturing tissue may include inserting a puncture needle into the lumen of a delivery catheter, wherein the puncture needle may include an elongated portion, a puncture component associated with a distal end of the elongated portion, and a spacer associated with a distal portion of the elongated portion. The method may include: advancing the puncture component of the puncture needle through a bend in the lumen of the delivery catheter, causing partial contact between the wall of the lumen of the delivery catheter and the spacer associated with the distal portion of the elongated portion to prevent contact between the puncture component and the wall as the puncture component is advanced through the bend in the delivery catheter; extending the puncture component through an outlet opening of the delivery catheter; and using the puncture component to puncture tissue at a target site to form an opening in the tissue.

[0018] In some embodiments, the method may include enlarging an opening in the tissue, wherein enlarging the opening includes inserting at least a portion of a spacer into the opening.

[0019] In some embodiments, puncturing tissue at the target site includes puncturing tissue from within the coronary sinus at a location on the left atrial wall. In some embodiments, the method may include inserting a delivery catheter via the femoral artery into the right atrium and then from the right atrium into the coronary sinus through the coronary sinus ostium.

[0020] In some embodiments, the puncture needle may include an elongated portion and a puncture component associated with the distal end of the elongated portion. The puncture component includes a blade edge on the distal edge, the blade edge being configured to puncture tissue at a target site. The puncture component is configured to advance through a lumen of a delivery catheter, and the blade edge does not stick to the wall of the lumen at a bend in the delivery catheter.

[0021] In some embodiments, the blade edge is located on a portion of the distal edge, which includes a blunt portion.

[0022] In some embodiments, the blade edge includes a convex curvature. In some embodiments, the blade edge is a convex curved blade edge. In some embodiments, the blade edge includes rounded segments. In some embodiments, the blade edge includes elliptical segments. In some embodiments, the blade edge includes a linear blade edge between opposing curved corners.

[0023] In some embodiments, the portion of the puncture member proximal to the blade edge has a width greater than the width of the blade edge. In some embodiments, the cross-section of the distal portion of the puncture member, taken along a plane extending between opposing portions of a pair of transverse surfaces, includes a circular segment on the distal portion of said circular segment, with the blade edge on the distal portion of said circular segment, and wherein the opposing portion of said circular segment proximal to the blade edge is blunt.

[0024] In some embodiments, the proximal portion of the puncture member has a width narrower than the width of the blade edge. In some embodiments, the proximal portion of the puncture member has the same width as the blade edge.

[0025] In some embodiments, the proximal portion of the puncture member has the same height as the distal portion of the puncture member. In some embodiments, the proximal portion of the puncture member has a greater height than the distal portion of the puncture member.

[0026] In some embodiments, the method of puncturing tissue may include inserting a puncture needle through the lumen of a delivery catheter. The puncture needle may include an elongated portion and a puncture member associated with a distal end of the elongated portion, and the puncture member may include a blade edge on a distal edge of the puncture member. The method may include: advancing the puncture needle through a bend in the delivery catheter without the puncture member becoming lodged against the wall of the lumen of the delivery catheter; extending the puncture member through an outlet opening on the delivery catheter; and using the blade edge to puncture tissue at a target site to form an opening at the target site.

[0027] In some implementations, the method may include enlarging an opening in the tissue, wherein enlarging the opening includes further inserting a puncture member into the opening.

[0028] In some embodiments, the cross-section of the distal portion of the puncture member, taken along a plane extending between opposing portions of a pair of transverse surfaces, includes a circular segment with a blade edge on the distal portion of the circular segment, and wherein the opposing portion of the segment near the blade edge is a blunt portion, and wherein enlarging the opening includes inserting the blunt portion into the opening to enlarge the opening non-invasively.

[0029] In some embodiments, puncturing tissue at the target site includes puncturing tissue from within the coronary sinus at a location on the left atrial wall. In some embodiments, the method may include inserting a delivery catheter transfemorally into the right atrium and then from the right atrium into the coronary sinus through the coronary sinus ostium. Attached Figure Description

[0030] Various embodiments are depicted in the accompanying drawings for illustrative purposes and should in no way be construed as limiting the scope of the invention. Furthermore, various features of different disclosed embodiments can be combined to form other embodiments, which are part of this disclosure. Reference numerals are reused throughout the drawings to indicate correspondences between reference elements. However, it should be understood that the use of similar reference numerals in conjunction with multiple drawings does not necessarily imply similarity between their associated corresponding embodiments. Moreover, it should be understood that the features in the various drawings are not necessarily drawn to scale, and their illustrative size is presented for the purpose of illustrating aspects of the invention. Generally, some of the illustrated features may be relatively smaller than those illustrated in some embodiments or configurations.

[0031] Figure 1 An example of a transcatheter pathway leading to the heart is shown.

[0032] Figure 2 This is a side view of an example of a puncture needle and an associated spacer positioned within the lumen of a delivery catheter.

[0033] Figure 3A and Figure 3B They were displayed respectively Figure 2 Three-dimensional and longitudinal cross-sectional views of the puncture needle and spacer.

[0034] Figure 4A and Figure 4B A perspective view and a longitudinal cross-sectional view of an example of a puncture needle and an associated spacer including an outwardly curved transverse surface are shown, respectively.

[0035] Figure 5A and Figure 5B A perspective view and a longitudinal cross-sectional view of an example of a puncture needle and an associated spacer including an inwardly curved transverse surface are shown, respectively.

[0036] Figure 6A and Figure 6B A perspective view and a longitudinal cross-sectional view are shown, respectively, of an example of a puncture needle and an associated spacer including an outwardly curved transverse surface, wherein the distal portion of the transverse surface has a smaller radius of curvature than the proximal portion of the transverse surface.

[0037] Figure 7A and Figure 7B A perspective view and a longitudinal cross-sectional view are shown, respectively, of an example of a puncture needle and an associated spacer including an outwardly curved transverse surface, wherein the proximal portion of the transverse surface has a smaller radius of curvature than the distal portion of the transverse surface.

[0038] Figure 8A and Figure 8BPerspective and longitudinal cross-sectional views of an example of a puncture needle and an associated spacer are shown, respectively, the spacer being asymmetrical about an axis collinear with the longitudinal axis of the puncture needle.

[0039] Figure 9A and Figure 9B A perspective view and a longitudinal cross-sectional view of an example of a puncture needle and an associated spacer are shown, the spacer comprising multiple plates positioned around an elongated portion of the puncture needle.

[0040] Figure 10A , Figure 10B and Figure 10C A perspective view, a distal view, and a longitudinal cross-sectional view of an example of a puncture needle and an associated spacer are shown, the spacer comprising a plurality of different outwardly curved portions positioned circumferentially around an elongated portion.

[0041] Figure 11 This is a flowchart of an example of a process for deploying a puncture needle that includes a spacer as described herein.

[0042] Figure 12 This is a longitudinal cross-sectional view of an example of a puncture needle system, which includes a protective shield for the distal end of a puncture needle.

[0043] Figure 13 This is a side view of an example of a puncture needle, which includes a puncture component having a curved blade edge positioned within the lumen of a delivery catheter.

[0044] Figure 14A , Figure 14B and Figure 14C They are Figure 13 A three-dimensional view, a top-down plan view, and a side view of the puncture needle.

[0045] Figure 15 This is a perspective view of an example of a puncture needle, which includes a puncture component having curved blade edges.

[0046] Figure 16 , Figure 17 , Figure 18 and Figure 19 This is a top-down plan view of an example of a puncture component with curved blade edges.

[0047] Figure 20 , Figure 21 , Figure 22 and Figure 23 It is a top-down plan view of an example of a piercing component with a blade edge, the blade edge comprising a linear or substantially linear portion extending between curve angles.

[0048] Figure 24 and Figure 25 It is a longitudinal cross-sectional view of an example including the puncture component at the edge of the blade.

[0049] Figure 26 This is a flowchart of an example of a process for deploying a puncture needle having a puncture component with a bladed edge as described herein. Detailed Implementation

[0050] The titles provided in this document are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0051] This disclosure relates to systems, apparatus, and methods for minimally invasive transcatheter delivery of medical implant devices and / or therapies to target tissue locations. A puncture needle is described herein that can be advanced from a proximal portion (including the proximal end) to a distal portion (including a puncture needle exit opening in the distal portion) of a delivery catheter's lumen, positioned within a tortuous anatomical path. The puncture needle can be used to puncture tissue at a target tissue location to achieve delivery of the medical implant device and / or therapy to the target tissue location. The puncture needle can be advanced through the lumen of the delivery catheter without becoming lodged within it, including through one or more bends and / or curvatures within the delivery catheter lumen.

[0052] Although certain preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, and to modifications and equivalents thereof. Therefore, the scope of the claims that may arise therefrom is not limited to any particular embodiment described below. For example, in any method or process disclosed herein, the actions or operations of said method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described sequentially as a plurality of discrete operations in a manner that aids in understanding certain embodiments; however, the order described should not be construed as implying that these operations are order-dependent. Furthermore, the structures, systems, and / or apparatuses described herein may be embodied as integrated components or separate components. For the purpose of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not all of these aspects or advantages are necessarily achieved by any particular embodiment. Therefore, for example, various embodiments may be performed in a manner that achieves or optimizes one or a set of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or implied herein.

[0053] For the purposes of preferred embodiments, certain standard anatomical location terms are used herein to refer to the anatomical structures of animals, i.e., humans. While certain spatially relative terms, such as “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms are used herein to describe the spatial relationship between one device / element or anatomical structure and another device / element or anatomical structure, it should be understood that these terms are used herein for ease of description to describe the positional relationship between elements(one or more) / structures(one or more), as exemplified in the accompanying drawings. It should be understood that, in addition to the orientations depicted in the accompanying drawings, spatially relative terms are intended to cover different orientations of elements(one or more) / structures(one or more) during use or operation. For example, an element / structure described as “above” another element / structure may present an alternative orientation relative to the patient or the element / structure, below or beside such other elements / structures, and vice versa.

[0054] Conventional needles used to create openings at target tissue sites in minimally invasive transcatheter approaches typically include a puncture component with a sharp distal end. Target tissue sites can be on the tissue of any number of internal blood vessels, channels, chambers, and / or organs. Advancing a puncture component with a sharp distal end through the lumen of a delivery catheter positioned in a tortuous anatomical path can cause the puncture needle to become lodged within the delivery catheter lumen. When the puncture component is inserted through the lumen, including through bends in the delivery catheter lumen, the sharp distal end may contact and become lodged within the lumen wall. The sharp distal end may puncture a portion of the lumen wall and subsequently become lodged against it, preventing the puncture needle from being inserted through the delivery catheter into the target tissue site. Conventional needles may fail to be inserted into the needle outlet opening of a delivery catheter lumen already positioned within a tortuous anatomical path. For example, a conventional needle may fail to advance from the proximal portion (including the proximal end) to the outlet opening on the distal portion of the delivery catheter lumen without becoming lodged within the delivery catheter lumen. Curves along anatomical pathways can create bends in the delivery catheter, thus preventing conventional needles from reaching the target site. Conventional needles may need to be pre-loaded into the delivery catheter lumen so that they only need to be advanced a short distance distal to the lumen to reach the needle exit opening located at or near the target site. The need to pre-load the needle into the delivery catheter lumen can prevent the lumen from being used for other purposes (e.g., preventing the needle from being replaced with another instrument), necessitating the use of delivery catheters with enlarged profiles.

[0055] The puncture needle described herein can be navigated through the lumen of a delivery catheter positioned along a tortuous anatomical path without becoming lodged within the lumen. As described herein, the puncture needle can be advanced from the proximal portion (e.g., proximal end) to the needle outlet opening on the distal portion of the delivery catheter lumen without becoming lodged within the lumen. The puncture needle can be advanced through one or more bends in the delivery catheter lumen without any part of the puncture needle becoming lodged within the lumen wall. The delivery catheter can be initially positioned within the anatomical path to place the needle outlet opening adjacent to or near the target tissue site, and the puncture needle can then be inserted through the positioned delivery catheter to reach the needle outlet opening. The delivery catheter does not require preloading of the puncture needle before positioning it within the anatomical path. The puncture needle can be inserted and / or retracted through the delivery catheter already positioned within the patient, allowing the puncture needle to be replaced with one or more other instruments. Such a puncture needle thus enables the use of delivery catheters with a smaller profile compared to those used to accommodate a preloaded puncture needle.

[0056] A puncture needle configured to advance through one or more bends in a delivery catheter lumen may include a spacer associated with an elongated portion of the puncture needle, and / or a puncture member including a distal edge of a blade edge thereon. The puncture member may be configured to puncture tissue and may be associated with the distal end of the elongated portion of the puncture needle. The spacer may be on the distal portion of the elongated portion, adjacent to the puncture member, or at a predetermined distance proximal to the puncture member. The spacer may include at least a portion extending laterally from the distal portion. The spacer may be configured to contact the wall of the delivery catheter lumen to prevent contact between the puncture member and the wall as the puncture member is advanced through the bends in the delivery catheter lumen. The spacer may be configured to contact the lumen wall of the delivery catheter to provide sufficient distance between the distal end of the puncture member and the lumen wall at and / or near the bends in the lumen, such that the distal end cannot contact the lumen wall at and / or near the bends. The spacer may prevent any portion of the puncture member from becoming lodged within the lumen wall, thereby facilitating needle insertion through the bends in the delivery catheter lumen. A puncture needle, including a spacer and a puncture component with a sharp distal end, can be advanced through one or more bends in the delivery catheter lumen without becoming stuck. Avoiding contact between the sharp distal end and the lumen wall also prevents damage to the lumen wall and / or to the sharp distal end, thus preventing the sharp distal end from becoming unsuitable for puncturing tissue to create an opening at the target tissue site.

[0057] In some embodiments, the spacer may extend radially from the distal portion of the elongated portion. In some embodiments, the spacer may be circumferentially positioned on the distal portion. For example, the spacer may be annular. In some embodiments, the spacer may be partially circumferentially positioned on the distal portion. In some embodiments, the spacer may include multiple distinct portions arranged around the distal portion. The spacer may include multiple individual plates. The spacer may include multiple distinct lateral surface portions. In some embodiments, the spacer may include multiple distinct portions partially circumferentially arranged around the distal portion.

[0058] The spacer may be symmetrical about an axis collinear with the longitudinal axis of the puncture needle. In some embodiments, the spacer is asymmetrical about the axis. The transverse surfaces of the spacer may be parallel or substantially parallel to the longitudinal axis of the puncture needle, and may be curved and / or arcuate outwards, and / or curved and / or arcuate inwards. For example, the transverse surfaces may include convex curvature and / or concave curvature. In some embodiments, the spacer may include multiple different transverse surface portions that are curved and / or arcuate outwards. In some embodiments, the shape of the spacer may be predetermined at least in part based on the expected direction and / or expected curvature of one or more bends in the delivery catheter lumen—including the expected direction and / or degree of the sharpest bend. In some embodiments, the shape of the spacer may be selected to facilitate the insertion and / or retraction of the spacer through the delivery catheter lumen, for example, to reduce friction between the spacer and the walls of the delivery catheter lumen.

[0059] In some embodiments, the width and / or length of the spacer may be selected based at least on the distance between the spacer and the distal end of the puncture member. For example, a spacer at a predetermined distance proximal to the puncture member may have a width wider and / or a length shorter than that of a spacer adjacent to the puncture member. In some embodiments, at least a portion of the spacer may be inserted into an opening formed at the target tissue site to act as a dilator for enlarging the opening. The spacer may include a width selected at least in part based on the desired enlargement of the opening.

[0060] In some embodiments, a puncture needle configured to be advanceable through one or more bends in a delivery catheter lumen may include a puncture member having a blade edge on its distal edge. The blade edge may be sharp to puncture tissue to create an opening at a target tissue site. In some embodiments, the blade edge may be a curved blade edge, such as a convex curved blade edge. In some embodiments, the blade edge may include a linear portion between opposing curved portions. For example, the blade edge may be a linear portion between rounded corners. The curvature of the blade edge can prevent the blade edge from getting stuck against the delivery catheter lumen wall. For example, a curved blade edge and / or a blade edge including a linear portion between opposing curved corners can contact the delivery catheter lumen wall at a bend in the delivery catheter lumen and slide along the wall without getting stuck. A puncture member having a blade edge on its distal edge may include a variety of shapes. In some embodiments, a puncture member including a blade edge may include a rounded paddle shape with the blade edge on the curved distal edge of the rounded paddle.

[0061] The puncture needle described herein can be used to create openings at various target tissue locations within the heart to enable the delivery of medical implants and / or therapies to the heart. Medical implants and / or therapies can be delivered to improve various cardiac abnormalities. In some embodiments, the puncture needle can be used to create an opening in the left atrial wall. For example, delivery of an implant and / or therapy to the heart can be performed to treat elevated pressure in the left atrium. The puncture needle can also be used to create an opening in a portion of the left atrial wall accessible from within the coronary sinus. Figure 1 An example of a path leading to the coronary sinus is shown, allowing a puncture needle to be positioned within the coronary sinus to access the wall of the left atrium (LA). An opening can be formed in the left atrial wall for the delivery of any number of medical therapies and / or medical devices, including the deployment of an expandable shunt into the left atrial wall. (Example...) Figure 1 As shown, the coronary sinus (CS) can be accessed via the right atrium (RA) through the coronary sinus ostium (CS ostium). The right atrium can also be accessed via the superior vena cava (SVC) or inferior vena cava (IVC). For example, access can be made via the superior vena cava through the jugular vein or subclavian vein. The delivery catheter for delivering the puncture needle can be inserted into the subclavian vein or jugular vein and advanced into the superior vena cava (e.g., along path A). Alternatively, the delivery catheter can be positioned into the inferior vena cava via the femoral artery (e.g., along path B). Other access routes can also be used to insert the delivery catheter into the vascular system.

[0062] The term “catheter” and / or “delivery catheter” as used herein may generally refer to or be applicable to any type of elongated tubular delivery device configured to slidably receive an instrument—such as an instrument for positioning within the atrium or coronary sinus—including, for example, delivery sheaths and / or cannulas.

[0063] The term “associated with” is used herein in its broad and general sense. For example, when a first feature, element, component, device, or member is described as “associated with a second feature, element, component, device, or member,” this description should be understood to indicate that the first feature, element, component, device, or member is physically coupled, attached, or connected to, integrated with, at least partially embedded in, or otherwise physically associated with, whether directly or indirectly, the second feature, element, component, device, or member.

[0064] As used herein, the term “cavity” can refer to a tubular cavity and / or space, and / or one or more structures that form, surround, and / or define a tubular cavity and / or space, including one or more surfaces that form, surround, and / or define a tubular cavity and / or space.

[0065] Figures 2 to 1 Figure 0 illustrates various examples of a puncture needle and an associated spacer. In some embodiments, the spacer may be integrally formed with the associated puncture needle, such as integrally formed with an elongated portion of the puncture needle. In some embodiments, the spacer and the elongated portion may be separable. For example, the spacer may be a distinct and separate component, wherein the spacer is configured to couple to the elongated portion. The spacer may be selected to couple to the elongated portion. Additionally, although the spacer is described as being associated with the elongated portion of the puncture needle, in some embodiments, the spacer may alternatively be associated with the distal outer portion of the puncture needle sheath. The puncture needle sheath may be configured to receive the puncture needle and, together with the puncture needle, be advanced through the delivery catheter lumen to or near the target tissue site. The spacer may be on the distal outer portion of the puncture needle sheath. In some embodiments, the puncture needle may be advanced relative to the puncture needle sheath such that the puncture needle can be used to puncture the target tissue. In some implementations, after the puncture needle sheath and puncture needle have been inserted into the target tissue site, the puncture needle sheath may be retracted relative to the puncture needle to facilitate the deployment of the puncture needle to puncture the tissue.

[0066] Spacers can be implemented in any number of suitable manners. In some embodiments, spacers can be pre-formed to include one or more configurations as described herein. In some embodiments, spacers can be configured to change from a crimped configuration to a deployed configuration in response to a trigger and / or actuation, the deployed configuration including one or more configurations as described herein. In some embodiments, spacers can include expandable members, for example, configured to expand before or after insertion into an anatomical pathway. Expandable members can be expanded such that the spacer can present one or more configurations as described herein.

[0067] Although reference Figures 2 to 1 The puncture component described in 0 has a tapered configuration, but it should be understood that the puncture component may include many other configurations, including a pre-curved puncture component with a sharp distal end.

[0068] Figure 2 This is a side view of an example of a puncture needle 100 and an associated spacer 150 positioned within the lumen 52 of a delivery catheter 50. A cross-sectional view of the delivery catheter 50 is shown. The puncture needle 100 may include an elongated portion 102, and the spacer 150 may be on a distal portion 104 of the elongated portion 102. The puncture needle 100 may include a puncture member 106 at the distal end (not shown) of the elongated portion 102. The puncture member 106 may include a proximal end 108 and a pointed distal end 110. For example, the puncture member 106 may include a tapered shape.

[0069] The spacer 150 may extend radially from the elongated portion and may be configured to contact the wall 54 of the lumen 52 as the puncture needle 100 is advanced through the lumen 52 to prevent contact between the wall 54 of the lumen 52 and the distal tip 110 of the puncture member 106. Contact between the distal tip 110 and the wall 54 may cause the distal tip 110 to become lodged within and / or against the wall 54, thereby causing the puncture needle 100 to become lodged within the lumen 52. Contact between the distal tip 110 and the wall 54 may damage the delivery catheter 50 and / or the distal tip 110. The spacer 150 may contact the wall 54 such that, as the puncture needle 100 is advanced through the lumen 52 of the delivery catheter (including when the puncture needle 100 is advanced through a bend in the lumen 52), a sufficient distance is maintained between the distal tip 110 and the wall 54 to prevent contact between the distal tip 110 and the wall 54. The puncture needle 100 can thus be inserted into and / or retracted through the delivery lumen 52 without becoming stuck in the lumen 52, thereby allowing the puncture needle 100 to be replaced with one or more other surgical instruments, including instruments for delivering one or more therapies and / or one or more medical devices to the target tissue site.

[0070] Spacer 150 may have a proximal end 152 and a distal end 154, and a lateral portion 156 extending between the proximal end 152 and the distal end 154. Spacer 150 may have a proximal edge portion 158 (such as the edge along which the proximal end 152 meets the lateral portion 156) and a distal edge portion 160 (such as the edge along which the distal end 154 meets the lateral portion 156). Figure 2 In the illustrated example, the puncture needle 100 is positioned within the bend of the delivery catheter lumen 52. In some embodiments, to prevent contact between the distal tip 110 and the wall 54, the lateral portion 156 of the spacer 150 may contact the wall 54 of the delivery catheter lumen 52 along the inner edge of the radius of curvature. In some embodiments, the proximal tip 152 and / or the proximal edge portion 158, and the distal tip 154 ​​and / or the distal edge portion 160, may contact the wall 54 along the outer edge of the radius of curvature of the bend. The contact between the wall 54 and the lateral portion 156, the proximal tip 152, the proximal edge portion 158, the distal tip 154, and / or the distal edge portion 160 provides sufficient space between the distal tip 110 and the wall 54 so that the distal tip 110 does not puncture the wall 54 when the puncture needle 100 is advanced through the bend.

[0071] In some embodiments, the spacer 150 may be adjacent to the puncture member 106. For example, the proximal end 108 of the puncture member 106 may be adjacent to the distal end 154 of the spacer 150. In some embodiments, the distal end 154 of the spacer 150 may be adjacent to the distal end of the elongated portion 102. The distal end 154 of the spacer 150 may be adjacent to the proximal end 108 of the puncture member 106. Alternatively, the spacer 150 may be located at a predetermined distance proximal to the puncture member 106. For example, the distal end 154 of the spacer 150 may be located at a predetermined distance proximal to the proximal end 108 of the puncture member 106. In some embodiments, the distal end 154 of the spacer 150 may be located at a predetermined distance proximal to the distal end of the elongated portion 102.

[0072] Figure 3A This is a perspective view of the puncture needle 100 and the spacer 150. The spacer 150 may be circumferentially positioned around the distal portion 104 of the elongated portion 102. For example, the spacer 150 may be annular. In some embodiments, the spacer 150 may be aligned with the longitudinal axis L of the puncture needle 100. 100 Coaxial. The spacer 150 surrounds the longitudinal axis L of the puncture needle 100. 100 Collinear axes can be symmetrical. Longitudinal axis L 100 It can extend along the length of the elongated portion 102 centrally, such as through the proximal portion (not shown) and the distal portion 104 of the elongated portion 102.

[0073] Figure 3BThe longitudinal cross-sectional view of spacer 150 is shown. The longitudinal cross-section can be along the longitudinal cross-sectional plane P. 150 Cut off. Longitudinal cross-sectional plane P 150 It can be extended from the distal portion 104 along the longitudinal axis L of the puncture needle 100. 100 Lateral extension. For example, the longitudinal cross-section of spacer 150 may include a rectangular or substantially rectangular shape. Lateral portion 156 may include a portion parallel to or substantially parallel to the longitudinal axis L of puncture needle 100. 100 The transverse surface is 162.

[0074] The width and / or length of the spacer 150 can be predetermined to prevent contact between the sharp distal end 110 and the lumen wall 54 of the delivery catheter. The length can be parallel or substantially parallel to the longitudinal axis L. 100 The longitudinal dimension. For example, the length can be a dimension extending between the proximal end 152 and the distal end 154 of the spacer 150. The width can be a transverse dimension that is perpendicular or substantially perpendicular to the length, such as perpendicular or substantially perpendicular to the longitudinal axis L of the puncture needle 100. 100 For example, the width can extend between opposite portions of the transverse surface 162.

[0075] As described herein, the spacer 150 may be adjacent to the puncture member 106, or optionally, at a predetermined distance proximal to the puncture member 106. In some embodiments, the width and / or length of the spacer 150 may be predetermined based at least in part on the distance between the spacer 150 and the distal tip 110 of the puncture member 106. In some embodiments, the width may be directly related to the distance between the spacer 150 (e.g., distal tip 154) and the distal tip 110. For example, a wider width may be chosen for a spacer positioned at a distance proximal to the puncture member 106 compared to a spacer positioned adjacent to the puncture member 106. In some embodiments, the length of the spacer 150 may be inversely related to the distance between the spacer 150 (e.g., distal tip 154) and the distal tip 110. For example, a shorter length may be chosen for a spacer positioned at a distance proximal to the puncture member 106 compared to a spacer positioned adjacent to the puncture member 106. In some implementations, the length does not depend on the distance between the spacer 150 and the pointed distal end 110.

[0076] In some embodiments, the proximal end 152 and / or distal end 154 may be flat or substantially flat surfaces. Optionally, the spacer 150 may include a proximal taper and / or a distal taper, such as tapers extending from the transverse portion 156 toward the proximal end 152 and / or distal end 154, respectively. The taper may include a curved taper and / or a linear taper. In some embodiments, the spacer 150 may include a proximal taper and / or a distal taper to facilitate retraction and / or insertion of the spacer 150 through the delivery catheter lumen 52.

[0077] In some embodiments, the spacer 150 may act as a dilator, configured to be inserted into an opening formed by the puncture member 106 at a target tissue site to enlarge the opening. The puncture needle 100 may be further advanced after the opening is formed, such that at least a portion of the spacer 150 is inserted into the opening. In some embodiments, the width of the spacer 150 may be selected at least in part based on the desired expansion of the opening. In some embodiments, the width of the spacer 150 may be selected to be not too large to impede insertion of the spacer 150 into the opening. In some embodiments, the spacer 150 may include a distal cone to facilitate insertion of the spacer 150 into the opening. In some embodiments, the spacer 150 is not configured to be inserted into the opening. In some embodiments, the distal end 154 of the spacer 150 may be flat or substantially flat to prevent or reduce insertion of the spacer 150 into the opening.

[0078] Figures 4 through 10 show other examples of spacers. Figure 4A This is a perspective view of an example of a puncture needle 200 and an associated spacer 250, the spacer 250 including an outwardly curved transverse surface 262. Figure 4B A longitudinal cross-sectional view of spacer 250 is shown. (Reference) Figure 4A The spacer 250 may be circumferentially positioned around the elongated portion 202 of the puncture needle 200. For example, the spacer 250 may extend radially from the distal portion 204 of the elongated portion 202. The spacer 250 may be annular. In some embodiments, the spacer 250 may be coaxial with the puncture needle 200. The spacer 250 surrounds the longitudinal axis L of the puncture needle 200. 200 The collinear axes can be symmetrical. The spacer 250 may have a proximal end 252 and a distal end 254, and a transverse portion 256 between the proximal end 252 and the distal end 254. The transverse portion 256 may include a transverse surface 262, which includes a convex curvature. For example, the transverse surface 262 may be outwardly curved and / or arcuate. Opposite portions of the transverse portion 256, such as opposite portions of the transverse surface 262, may contact the wall of the delivery catheter lumen along the inner and outer edges of the curvature within the delivery catheter lumen.

[0079] refer to Figure 4B Spacer 250 along longitudinal cross-sectional plane P 250 The longitudinal cross-section may include a circular segment. For example, the convex curvature may have a uniform or substantially uniform radius of curvature. In some embodiments, along the longitudinal cross-sectional plane P 250 The longitudinal cross-section may include elliptical segments. The longitudinal cross-section plane P 250 From the distal portion 204 of the elongated portion 202 along the longitudinal axis L 200 Lateral extension. The lateral portion 256, which includes an outward curvature, can reduce contact, thereby reducing friction between the spacer 250 and the lumen wall of the delivery catheter, to facilitate the insertion and / or retraction of the puncture needle 200 through the lumen of the delivery catheter.

[0080] Figure 5A This is a perspective view of an example of a puncture needle 300 and an associated spacer 350, the spacer 350 including an inwardly curved transverse surface 362. Figure 5B A longitudinal cross-sectional view of spacer 350 is shown. (Reference) Figure 5A The spacer 350 may be circumferentially positioned around the elongated portion 302 of the puncture needle 300, such as around the distal portion 304 of the elongated portion 302. The spacer 350 may be annular. In some embodiments, the spacer 350 may be coaxial with the puncture needle 300. The spacer 350 surrounds the longitudinal axis L of the puncture needle 300. 300 The collinear axes can be symmetrical. The spacer 350 may have a proximal end 352, a distal end 354, and a transverse portion 356 between the proximal end 352 and the distal end 354. The transverse portion 356 may have a transverse surface 362. The transverse surface 362 may include a concave curvature. For example, the transverse surface 362 may be inwardly curved or arc-shaped.

[0081] refer to Figure 5B The image shows a longitudinal cross-sectional view of spacer 350. The longitudinal cross-section of spacer 350 can be viewed along the longitudinal cross-sectional plane P. 350 Cut off. Longitudinal cross-sectional plane P 350 It can be seen from the distal portion 304 of the elongated portion 302 along the longitudinal axis L 300 The transverse portion 356 extends laterally. Its longitudinal cross-section may include a concave curvature, with the transverse surface 362 curving inwards. In some embodiments, the concave curvature may have a uniform radius of curvature. For example, the concave curvature may include circular segments. In some embodiments, the radius of curvature of the concave curvature may be non-uniform. For example, the concave curvature may include elliptical segments.

[0082] The spacer 350 may have a proximal edge portion 358 (such as the edge along which the proximal end 352 meets the transverse portion 356) and a distal edge portion 360 (such as the edge along which the distal end 354 meets the transverse portion 356). In some embodiments, as the puncture needle 300 is advanced through a bend in the delivery catheter lumen, the transverse portion 356 may contact the wall of the delivery catheter lumen along the inner edge of the curvature in the bend. In some embodiments, the proximal end 352 and / or the proximal edge portion 358, and the distal end 354 and / or the distal edge portion 360, may contact the wall along the outer edge of the curvature in the delivery catheter lumen. In some embodiments, the concave curvature of the transverse portion 356 may provide reduced contact between the spacer 350 and the wall of the delivery catheter lumen, thereby reducing friction between the spacer 350 and the wall of the delivery catheter lumen to facilitate insertion and / or retraction of the puncture needle 300.

[0083] Figure 6A This is a perspective view of an example of a puncture needle 400 and an associated spacer 450, wherein the spacer 450 includes an outwardly curved transverse surface 462, the distal portion of which has a smaller radius of curvature than the proximal portion of which. Figure 6B A longitudinal cross-sectional view of spacer 450 is shown. (Reference) Figure 6A The spacer 450 may be circumferentially positioned around the elongated portion 402 of the puncture needle 400 (such as the distal portion 404 of the elongated portion 402). In some embodiments, the spacer 450 may be coaxial with the puncture needle 400. The spacer 450 surrounds the longitudinal axis L of the puncture needle 400. 400 The collinear axes can be symmetrical. The spacer 450 may have a proximal end 452, a distal end 454, and a lateral portion 456 between the proximal end 452 and the distal end 454. The lateral portion 456 may have a lateral surface 462. The lateral portion 456 may include an outwardly arcuate shape and / or curvature having a non-uniform radius of curvature. For example, the lateral surface 462 may include a convex curvature having a non-uniform radius of curvature, wherein the radius of curvature increases along a direction extending from the distal end 454 to the proximal end 452. The distal portion 460 of the lateral surface 462 may have a smaller radius of curvature than the proximal portion 458 of the lateral surface 462.

[0084] refer to Figure 6B This shows the plane P along the longitudinal cross-section. 450 The longitudinal cross-section of the spacer at 45°. Longitudinal cross-section plane P. 450 From the distal portion 404 along the longitudinal axis L 400Laterally extending. As shown in the longitudinal cross-section of spacer 450, lateral surface 462 may include a convex curvature, wherein the radius of curvature increases along a direction extending from distal end 454 toward proximal end 452. The width of spacer 450 may generally decrease along a direction extending from distal end 454 toward proximal end 452. The width of spacer 450 may be a dimension extending between opposing portions of lateral surface 462. In some embodiments, the longitudinal cross-section of spacer 450 may include teardrop-shaped segments, wherein the wider portions of said segments are oriented toward the puncture member 406 of puncture needle 400. When puncture needle 400 is inserted through a bend in the delivery catheter lumen, opposing portions of lateral surface 462 may contact the wall of the delivery catheter lumen along the inner and outer edges of the bend. For example, opposing portions of the distal portion 460 of lateral surface 462 may contact the wall of the delivery catheter lumen along the inner and outer edges of the bend.

[0085] Figure 7A This is a perspective view of an example of a puncture needle 500 and an associated spacer 550, wherein the spacer 550 includes an outwardly curved transverse surface 562, the proximal portion 558 of the transverse surface 562 having a smaller radius of curvature than the distal portion 560 of the transverse surface 562. Figure 7B A longitudinal cross-sectional view of spacer 550 is shown. Spacer 550 may have the same characteristics as referenced... Figure 6A and Figure 6B The spacer 450 is described as having an orientation opposite to that of spacer 450. Spacer 550 may include other features that are the same as or similar to those of spacer 450. For example, refer to... Figure 7A The spacer 550 may be circumferentially positioned around the distal portion 504 of the elongated portion 502. In some embodiments, the spacer 550 may be coaxial with the puncture needle 500. The spacer 550 surrounds the longitudinal axis L of the puncture needle 500. 500 Collinear axes can be symmetrical. (See reference) Figure 7B Spacer 550 along longitudinal cross-sectional plane P 550 The longitudinal cross-section shows that the transverse surface 562 of the transverse portion 556 extending between the proximal end 552 and the distal end 554 can have a convex curvature. The convex curvature can have a radius of curvature that decreases along the direction extending from the distal end 554 toward the proximal end 552. (Longitudinal cross-sectional plane P) 550 From the distal portion 504 along the longitudinal axis L 500Laterally extended. The width of the spacer 550 (e.g., the dimension extending between opposing portions of the lateral surface 562) may generally increase along a direction extending from the distal end 554 to the proximal end 552. In some embodiments, the longitudinal cross-section of the spacer 550 may include teardrop-shaped segments, wherein the wider portions of said segments are oriented away from the puncture member 506 of the puncture needle 500. When the puncture needle 500 is inserted through the bend in the delivery catheter lumen, opposing portions of the lateral surface 562 may contact the wall of the delivery catheter lumen along the inner and outer edges of the bend. For example, opposing portions of the proximal portion 558 of the lateral surface 562 may contact the wall of the delivery catheter lumen along the inner and outer edges of the bend.

[0086] Figure 8A This is a perspective view of an example of a puncture needle 600 and an associated spacer 650, the spacer 650 being about a longitudinal axis L of the puncture needle 600. 600 The collinear axes are asymmetrical. The puncture needle 600 may have a puncture member 606 at the distal end of its elongated portion. The spacer 650 may be coaxial with the puncture needle 600. Figure 8B This is a longitudinal cross-sectional view of a 600mm puncture needle. (Reference) Figure 8A The spacer 650 may be circumferentially positioned around the distal portion 604 of the elongated portion 602. The spacer 650 may have a proximal end 652, a distal end 654, and a lateral portion 656 between the proximal end 652 and the distal end 654. The lateral portion 656 may have a lateral surface 662. The lateral surface 662 may meet with the proximal end 652 and the distal end 654 to form a proximal edge portion 658 and a distal edge portion 660, respectively. The lateral portion 656 may include outward curvature and inward curvature. For example, opposing portions of the lateral surface 662 may include convex curvature and concave curvature, such that the spacer 650 about the longitudinal axis L. 600 It is asymmetrical.

[0087] refer to Figure 8B The image shows a longitudinal cross-sectional view of spacer 650. It also shows spacer 650 along the longitudinal cross-sectional plane P. 650 The longitudinal cross-section. Longitudinal cross-section plane P 650 It can be along the longitudinal axis L 600 It extends laterally from the distal portion 604 in the opposite direction. The spacer 650 is along the cross-sectional plane P. 650 The longitudinal cross-section shows that the transverse surface 662 may include both convex and concave curvature. For example, a first portion of the transverse surface 662 may include convex curvature, while a portion of the transverse surface 662 opposite to the first portion may include concave curvature. In some embodiments, the radii of curvature of the convex and / or concave curves may be uniform or substantially uniform. In some embodiments, the radii of curvature of the convex and / or concave curves may be non-uniform.

[0088] In some embodiments, the orientation of the convex and concave curvatures may depend on the expected curvature of a known bend in the anatomical path through which the delivery catheter is advanced. For example, the orientation may be selected based on the direction of the sharpest bend expected in the anatomical path, and thus on the direction of the sharpest bend expected in the delivery catheter lumen. In some embodiments, the concave portion of the transverse surface 662 may be configured to oriented toward the outer edge of the bend, while the convex portion of the transverse surface 662 may be oriented toward the inner edge of the bend. In some embodiments, the convex portion of the transverse surface 662 may contact the delivery catheter lumen wall along the inner edge of the bend. In some embodiments, the proximal end 652 and / or the proximal edge portion 658, and the distal end 654 and / or the distal edge portion 660 may contact the delivery catheter lumen wall along the outer edge.

[0089] In some embodiments, the spacer, which is asymmetrical about an axis collinear with the longitudinal axis of the puncture needle, may include other configurations. For example, the opposing transverse surface portions may include curved portions (such as convex curvature and / or concave curvature) and portions parallel or substantially parallel to the longitudinal axis.

[0090] Figure 9A and Figure 9B An example of a puncture needle 700 and an associated spacer 750 is shown. The spacer 750 includes a pair of plates positioned in an opposing manner on an elongated portion 702 of the puncture needle 700. The puncture needle 700 may have a puncture member 706 at the distal end of the elongated portion 702. Figure 9A It is a 3D image, and Figure 9B This is a longitudinal cross-sectional view. The spacer 750 may include a plurality of discrete plates arranged around the distal portion 704 of the elongated portion 702. For example, the spacer 750 may include a first plate 750a and a second plate 750b arranged around the distal portion 704 of the elongated portion 702. The first plate 750a and the second plate 750b may be arranged in a relative manner around the distal portion 704. The plates 750a and 750b may be partially arranged circumferentially around the distal portion 704. For example, the plates 750a and 750b may each include an arcuate shape and may be spaced apart from each other by a pair of opposing gaps (in... Figure 9A(Only one of the gaps is visible). Plates 750a and 750b may be arranged to surround corresponding portions of the elongated portion 702. In some embodiments, the first plate 750a and the second plate 750b may have the same or similar configuration. In some embodiments, separation between the plates may provide increased flexibility to facilitate insertion of the spacer 750 through a delivery catheter lumen placed within a tortuous anatomical path. The gap separating the first plate 750a and the second plate 750b may be predetermined to provide increased flexibility while allowing the spacer 750 to maintain the desired distance between the puncture member 706 and the wall of the delivery catheter lumen.

[0091] The first plate 750a and the second plate 750b may each include a proximal end 752a, 752b, a distal end 754a, 754b, and a lateral portion 756a, 756b. Each lateral portion 756a, 756b may include a lateral surface 762a, 762b. The first plate 750a may include a proximal edge portion 758a (e.g., the edge along which the proximal end 752a meets the lateral portion 756a) and a distal edge portion 760a (e.g., the edge along which the distal end 754a meets the lateral portion 756a). The second plate 750b may include a second proximal edge portion 758b (e.g., the edge along which the second proximal end 752b meets the second lateral portion 756b) and a second distal edge portion 760b (e.g., the edge along which the second distal end 754b meets the second lateral portion 756b). For example, as the puncture needle 700 is advanced through the bend in the delivery catheter lumen, the first transverse surface 762a may contact the lumen wall along the inner edge of the bend. In some embodiments, the second proximal end 752b and / or the second proximal edge portion 758b, and the second distal end 754b and / or the second distal edge portion 760b may contact the lumen wall along the outer edge of the bend. In some embodiments, the second transverse surface 762b may contact the lumen wall along the inner edge of the bend, and the first proximal end 752a and / or the first proximal edge portion 758a, and the first distal end 754a and / or the first distal edge portion 760a may contact the lumen wall along the outer edge of the bend.

[0092] Figure 9B The cross-sectional view is along the longitudinal cross-sectional plane P. 750 The cut-off. Longitudinal cross-sectional plane P. 750 From the distal portion 704 of the elongated portion 702 along the longitudinal axis P 750Laterally extended. A longitudinal cross-section of the first plate 750a and the second plate 750b is shown. In some embodiments, connector members 770a, 770b can couple the first plate 750a and the second plate 750b to the distal portion 704 of the elongated portion 702. The lateral portions 756a, 756b of the first plate 750a and the second plate 750b may be parallel or substantially parallel to the elongated portion 702.

[0093] It should be understood that the number and / or shape of plates 750a and 750b are used for illustrative purposes. In some embodiments, the spacer may have more than two plates arranged around the elongated portion of the puncture needle. In some embodiments, one or more of the plates may include different shapes. For example, one or more of the plates may include one or more shapes as described herein, including plates having outward curvature and / or inward curvature. The transverse surfaces of the plates may include convex curvature and / or concave curvature, wherein the curvature may or may not have a uniform radius of curvature.

[0094] Figure 10A , Figure 10B and Figure 10C An example of a puncture needle 800 and an associated spacer 850 is shown. The spacer 850 includes a plurality of different outwardly curved portions positioned circumferentially around an elongated portion 802 of the puncture needle 800. The puncture needle 800 may have a puncture member 806 at the distal end of the elongated portion 802. Figure 10A It is a 3D image of the puncture needle 800, and Figure 10B This is a view of the puncture needle 800 from the distal end. (Reference) Figure 10A The spacer 850 may include four portions 850a, 850b, 850c (not shown), and 850d, positioned around the distal portion 804 of the elongated portion 802. In some embodiments, the four portions 850a, 850b, 850c, and 850d may be four uniform or substantially uniform portions evenly distributed around the distal portion 804, each of the four portions 850a, 850b, 850c, and 850d including an outwardly arcuate shape. The four portions 850a, 850b, 850c, and 850d may be four different, uniform or substantially uniform lobes evenly distributed around the circumference of the distal portion 804. The four portions 850a, 850b, 850c, and 850d in Figure 10B It is displayed in the middle.

[0095] The spacer 850 may have a proximal end 852 and a distal end 854. Each of the four portions 850a, 850b, 850c, 850d may have a corresponding lateral portion 856a, 856b, 856c, 856d between the proximal end 852 and the distal end 854. Each lateral portion 856a, 856b, 856c, 856d may include a corresponding lateral surface 862a, 862b, 862c, 862d. In some embodiments, each of the lateral portions 856a, 856b, 856c, 856d may include an outward curvature, such as a convex curvature. For example, each of the four different lateral surfaces 862a, 862b, 862c, 862d may include a convex curvature. The transverse portions 856a, 856b, 856c, and 856d may each include convex curvature along both the longitudinal and transverse axes, wherein the transverse axis is perpendicular or substantially perpendicular to the longitudinal axis. As further described herein, the longitudinal axis may be along a longitudinal axis L parallel or substantially parallel to the puncture needle 800. 800 Extending in the direction of L. For example, the longitudinal axis can be aligned with L. 800 Collinear. In some embodiments, the transverse cross-sections of the respective transverse portions 856a, 856b, 856c, 856d along a plane extending along the transverse axis may include convex curvature. The radius of curvature of the convex curve may be uniform or may not be uniform. In some embodiments, the transverse cross-section may include circular segments. In some embodiments, the transverse cross-section may include elliptical segments.

[0096] exist Figure 10C The image shows a longitudinal cross-sectional view of the spacer 850. Specifically, it shows the spacer 850 along the longitudinal cross-sectional plane P. 850 The longitudinal cross-sectional view. Longitudinal cross-sectional plane P 850 From the distal portion 804 of the elongated portion 802 along the longitudinal axis L 800 Lateral extension. In some embodiments, the longitudinal cross-section of spacer 850 may include a circular segment. In some embodiments, the longitudinal cross-section of spacer 850 may include an elliptical segment. For example, the longitudinal cross-section of lateral portions 856a, 856b, 856c, 856d may include a circular or elliptical segment. Lateral surfaces 862a, 862b, 862c, 862d may include a convex curvature. The radius of curvature may be uniform or may not be uniform.

[0097] In some embodiments, the spacer may include more or fewer different lateral surface portions. One or more of these different lateral surface portions may be curved and / or arcuate inward, for example, including concave curvature. The curvature in the one or more lateral surface portions may reduce friction between the spacer and the lumen wall of the delivery catheter, thereby facilitating the insertion and / or retraction of the spacer. One or more of these different lateral surface portions may be parallel or substantially parallel to the longitudinal axis of the associated puncture needle. In some embodiments, the spacer may be asymmetrical about an axis coaxial with the longitudinal axis of the puncture needle. In some embodiments, the shape of the spacer may be predetermined based on the expected direction and / or degree of one or more bends in the delivery catheter lumen (including the expected direction and / or degree of the sharpest bend).

[0098] As described herein, spacers may be adjacent to or at a predetermined distance from the puncture member. For example, spacers 250, 350, 450, 550, 650, 750, and 850, as described with reference to Figures 4 through 10, may be adjacent to or at a predetermined distance from their respective puncture members 206, 306, 406, 506, 606, 706, and 806. The distal ends 254, 354, 454, 554, 654, 754, and 854 of the respective spacers 206, 306, 406, 506, 606, 706, and 806 may be adjacent to the respective proximal ends 208, 308, 408, 508, 608, and 708 of the respective puncture components 206, 306, 406, 506, 606, 706, and 806, or at a predetermined distance proximal to the respective proximal ends 208, 308, 408, 508, 608, and 708 of the respective puncture components 206, 306, 406, 506, 606, 706, and 806.

[0099] In some embodiments, the width and / or length of the spacers 250, 350, 450, 550, 650, 750, 850 may be predetermined at least in part based on the distance between the spacers 250, 350, 450, 550, 650, 750, 850 and the respective distal tips 210, 310, 410, 510, 610, 710, 810 of the puncture needles 206, 306, 406, 506, 606, 706, 806. The length may be a longitudinal dimension parallel to or substantially parallel to the longitudinal axis of the respective puncture needles 200, 300, 400, 500, 600, 700, 800. The width may be a lateral dimension perpendicular to or substantially perpendicular to the length (e.g., perpendicular to or substantially perpendicular to the longitudinal axis of the puncture needles 200, 300, 400, 500, 600, 700, 800). In some embodiments, the width may be directly related to the distance. In some embodiments, the length may be negatively related to the distance. In some embodiments, the length does not depend on the distance between the spacers 250, 350, 450, 550, 650, 750, 850 and the respective sharp distal ends 210, 310, 410, 510, 610, 710, 810 of the piercing members 206, 306, 406, 506, 606, 706, 806.

[0100] As shown in Figures 4 to 10, the proximal ends 252, 352, 452, 552, 652, 752, 852 and / or the distal ends 254, 354, 454, 554, 654, 754, 854 can be flat or substantially flat surfaces. Optionally, the spacers 250, 350, 450, 550, 650, 750, 850 can include proximal or distal cones, such as cones extending from the lateral portions 256, 356, 456, 556, 656, 756, 856 toward the proximal ends 252, 352, 452, 552, 652, 752, 852 and / or the distal ends 254, 354, 454, 554, 654, 754, 854, respectively. The cones can include curved cones and / or linear cones. Spacers 250, 350, 450, 550, 650, 750, and 850 may include a proximal cone and / or a distal cone to facilitate retraction and / or insertion of spacers 250, 350, 450, 550, 650, 750, and 850 through the delivery catheter lumen.

[0101] In some embodiments, spacers 250, 350, 450, 550, 650, 750, and 850 may act as expanders, configured to be inserted into an opening formed at a target tissue site to enlarge the opening. In some embodiments, the width of spacers 250, 350, 450, 550, 650, 750, and 850 may be selected at least in part based on the desired expansion of the opening. In some embodiments, spacers 250, 350, 450, 550, 650, 750, and 850 may include a distal cone to facilitate insertion of spacers 250, 350, 450, 550, 650, 750, and 850 into the opening. In some embodiments, the distal ends 254, 354, 454, 554, 654, 754, 854 may be flat or substantially flat to prevent or reduce the insertion of spacers 250, 350, 450, 550, 650, 750, 850 into the opening.

[0102] Figure 11 This is a flowchart illustrating an example of a procedure 1100 for deploying a puncture needle including a spacer as described herein. In block 1102, procedure 1100 involves inserting a puncture needle and an associated spacer into a delivery catheter lumen. The puncture needle may include an elongated portion, and the spacer may be positioned on a distal portion of the elongated portion. The puncture component may include a sharp distal end that may become lodged within the wall of the delivery catheter lumen if it contacts the wall.

[0103] In block 1104, process 1100 involves advancing a puncture needle through a bend in the lumen of a delivery catheter. For example, the puncture component may be inserted through the bend in the lumen of the delivery catheter without becoming lodged within it. In block 1106, process 1100 involves contacting a spacer with the wall of the delivery catheter lumen to prevent contact between the wall and the puncture component of the puncture needle. The spacer may contact the wall to provide space between the delivery catheter lumen wall and the distal tip of the puncture component, preventing the distal tip from contacting the wall.

[0104] In block 1108, process 1100 involves extending a puncture component through the outlet opening of a delivery catheter to puncture tissue at a target site. The target tissue site can be on any number of internal blood vessels, channels, organs, and / or chambers. In some embodiments, the target site can be on the left atrial wall. In some embodiments, the puncture needle can be positioned within the coronary sinus to allow access to the left atrial wall from within the coronary sinus. For example, the delivery catheter can be positioned from the right atrium via the coronary sinus ostium into the coronary sinus using a transfemoral approach. The puncture needle can then be deployed from the lumen of the delivery catheter to form an opening in the left atrial wall from within the coronary sinus. In some embodiments, a transclavian or transjugular approach can be used.

[0105] In some embodiments, after the opening is formed, at least a portion of the spacer may optionally be inserted into the opening to enlarge it. As described herein, in some embodiments, the width of the spacer may be selected based on the desired enlargement of the opening formed in the tissue. In some embodiments, the spacer may be configured to reduce or eliminate insertion into the opening in the target tissue.

[0106] As described herein, although the spacer is described as being associated with an elongated portion of the puncture needle, in some embodiments, the spacer may alternatively be associated with the distal outer portion of a puncture needle sheath configured to receive the puncture needle. The spacer may be on the outer portion of the puncture needle sheath, such as the distal outer portion. After positioning the puncture needle sheath and puncture needle in the desired location relative to the target tissue site, the puncture needle sheath may be retracted and / or the puncture needle may be advanced to deploy the puncture needle for puncturing the target tissue.

[0107] Figure 12 This is a longitudinal cross-sectional view of an example of a puncture needle system 1200. The puncture needle system 1200 may include a puncture needle 1210 and a protective cover 1250 above the puncture needle 1210. Figure 12 A puncture needle system 1200 positioned within a lumen 1204 of a delivery catheter 1202 is shown. The puncture needle 1210 may include an elongated portion 1212 and a puncture member 1216 at a distal end 1214 of the elongated portion 1212. The puncture member 1216 may have a pointed distal end 1218, and a protective shield 1250 may extend over the pointed distal end 1218 to prevent the pointed distal end 1218 from contacting the wall 1206 of the delivery catheter lumen 1204. For example, the protective shield 1250 (such as the distal portion 1252 of the protective shield 1250) may be held above the pointed distal end 1218 as the puncture needle 1210 is advanced through any bend in the delivery catheter lumen 1204, preventing the pointed distal end 1218 from contacting the wall 1206.

[0108] A protective shield 1250 may extend over at least a portion of the puncture needle 1210 (including over the puncture member 1216). The delivery catheter 1202 may be positioned at the desired location. Subsequently, the puncture needle 1210 and the protective shield 1250 may be inserted through the delivery catheter lumen 1204 to position the puncture needle 1210 at or near a target tissue site for creating an opening in said tissue. For example, the puncture member 1216, enclosed within the protective shield 1250, may be advanced through the delivery catheter lumen 1204 until the puncture member 1216 is positioned at or near a target tissue site. After the puncture member 1216 is positioned at or near a target tissue site, the puncture needle 1210 may be translated distally relative to the protective shield 1250 to allow the puncture member 1216 to pierce the distal portion 1252 of the protective shield 1250. The unsheathed puncture member 1216 may be used to pierce the target tissue to create an opening in the target tissue. The puncture component 1216 can be further extended, for example, through the puncture needle outlet opening of the delivery catheter 1202, so that the puncture component 1216 can be used to puncture tissue at the target site.

[0109] Figures 13 to 25 Various examples of puncture needles are shown, which have a puncture component with a bladed edge on their distal edge. The bladed edge can be sharp to cut through tissue, thereby creating an opening at the target tissue site. In some embodiments, the bladed edge may include a convex curvature. The bladed edge can be a convex, curved bladed edge. The bladed edge may include a linear portion between opposing curve angles. As described herein, conventional puncture components typically include a sharp distal end. When the sharp distal end contacts the wall of the delivery catheter lumen, such as when the puncture component is advanced through a bend in the delivery catheter lumen, the sharp distal end of the puncture component can become lodged within the wall. The sharp distal end can puncture and become lodged against the delivery catheter lumen wall, causing the puncture needle to become lodged within the delivery catheter lumen. In contrast, when the bladed edge contacts the wall of the delivery catheter lumen, the curvature in the bladed edge can prevent the bladed edge from becoming lodged against the wall. For example, when the bladed edge contacts the wall at a bend in the delivery catheter lumen, a convex, curved bladed edge and / or a bladed edge including a linear portion between opposing rounded angles can slide along the wall without becoming lodged against it. A puncture needle, including the blade edge as described herein, can thus be advanced through one or more bends in the delivery catheter lumen.

[0110] Figure 13An example of a puncture needle 1300 positioned within a delivery catheter 1350 is shown, wherein the puncture needle 1300 includes a puncture member 1310 having a blade edge 1320. In some embodiments, the puncture member 1310 may include a rounded paddle shape, wherein the blade edge 1320 is on at least a portion of the rounded distal edge of the paddle. The blade edge 1320 may be a sharp edge configured to puncture tissue. If the blade edge 1320 contacts the wall 1354 of the delivery catheter lumen 1352, the blade edge 1320 may slide along the wall 1354 without any portion of the blade edge 1320 becoming stuck within the wall 1354. For example, as the puncture member 1310 is advanced through a bend in the delivery catheter lumen 1354, the blade edge 1320 may contact the delivery catheter lumen wall 1354 without any portion of the blade edge 1320 becoming stuck on the wall 1354. The blade edge 1320 can advantageously facilitate the insertion of the puncture needle 1300 through the bend in the delivery catheter lumen 1352 without the puncture needle 1300 getting stuck in the lumen 1352.

[0111] refer to Figure 13 The puncture needle 1300 may include an elongated portion 1302, and the puncture member 1310 may be located at the distal end 1304 of the elongated portion 1302. The puncture member 1310 may have a proximal portion 1312 and a distal portion 1314. The proximal portion 1312 may include a proximal end 1316 adjacent to the distal end 1304 of the elongated portion 1302. The distal portion 1314 may include a distal edge 1318, which includes a blade edge 1320. The distal portion 1314 may include a curved edge, such as a convex curve. The distal edge 1318 may include a curved edge such that the blade edge 1320 is a curved blade edge. The radius of curvature of the curved edge may be uniform or may not be uniform. In some embodiments, the distal portion 1314 may include circular segments and / or elliptical segments. The blade edge 1320 may include circular segments and / or elliptical segments.

[0112] Figure 14A This is a perspective view of the puncture needle 1300. The puncture member 1310 may have two opposing surfaces 1322, 1324 that converge along their respective distal edges to form a distal edge 1318. For example, the opposing surfaces 1322, 1324 may be the top and bottom surfaces of the puncture member 1310, respectively. The opposing surfaces 1322, 1324 may be flat or substantially flat. In some embodiments, only a portion of the distal edge 1318 includes the blade edge 1320. For example, a portion of the distal edge 1318 may be blunt. In some embodiments, the blade edge 1320 may extend along the entire or substantially the entire distal edge 1318. For example, the opposing surfaces 1322, 1324 may converge to form a sharp blade edge 1320.

[0113] The transverse surfaces 1326, 1328 of the puncture member 1310 may extend between two opposing surfaces 1322, 1324. In some embodiments, the transverse surfaces 1326, 1328 are not arcuate and / or curved, or substantially not arcuate and / or curved, along the dimension extending between the two opposing surfaces 1322, 1324. The width of the puncture member 1310 (e.g., W) 1300 The width W can be the dimension extending between the respective portions of the transverse surfaces 1326 and 1328. 1300 It can be a dimension extending between opposite portions of the transverse surfaces 1326 and 1328. For example, the width W 1300 It can extend between a portion of the transverse surface 1326 and a portion of the transverse surface 1328 opposite to said portion of the transverse surface 1326. The height of the piercing member 1310 (e.g., H) 1300 The height can be a dimension extending between respective portions of the opposing surfaces 1322, 1324. The height can be a dimension extending between opposing portions of surfaces 1322, 1324, and between a portion of the top surface 1322 and a portion of the bottom surface 1324 opposite the portion of the top surface 1322. For example, the height can be perpendicular or substantially perpendicular to the longitudinal axis L of the puncture needle 1300. 1300 The dimensions. The width can be perpendicular or substantially perpendicular to the height and longitudinal axis L of the puncture needle (1300). 1300 The dimensions of both.

[0114] Figure 14B A top-down plan view of the puncture needle 1300 is shown. Figure 14C A side view of the puncture needle 1300 is shown. (Reference) Figure 14BThe proximal portion 1312 may have a width that increases in the direction extending from the proximal end 1316 toward the distal portion 1314. In some embodiments, the top surface 1322 and the bottom surface 1324 may be flat. In some embodiments, the top surface 1322 and the bottom surface 1324 are parallel or substantially parallel to each other. In some embodiments, a cross-section of the proximal portion 1312 taken along a plane parallel or substantially parallel to the top surface 1322 or the bottom surface 1324 may include a trapezoidal shape. For example, a cross-section of the proximal portion 1312 taken along a plane parallel or substantially parallel to the top surface 1322 or the bottom surface 1324 and including a portion of the transverse surface 1326 and a portion of the transverse surface 1328 opposite to said portion of the transverse surface 1326 may include a trapezoidal shape. The trapezoidal shape may have a pair of opposing parallel sides, wherein the shorter parallel side is positioned proximal and the longer parallel side is positioned distal. A cross-section of the distal portion 1314 taken along the same plane may include a circular segment. For example, the cross-section of the distal portion 1314 may include a semicircle, with the blade edge 1320 on at least a portion of said semicircle. The blade edge 1320 may be on the distal portion of the circular segment, and the opposing portion of said segment proximal to the blade edge 1320 may be a blunt portion. A portion of the puncture member 1310 may include a width that increases along a direction extending from the distal edge 1318 toward the proximal portion 1312 to facilitate the use of the puncture member 1310 as a dilator to enlarge the opening formed using the blade edge 1320.

[0115] In some embodiments, the rounded edge (e.g., a semi-circular shape) of the distal portion 1314 can facilitate the enlargement of the opening formed by the blade edge 1320 using the puncture member 1310. The rounded edge can facilitate gradual expansion of the opening. Because one or more blunt portions of the puncture member 1310 can be used to perform the enlargement, non-invasive incremental enlargement can be achieved. For example, enlarging the opening may include inserting a blunt portion on the semi-circular segment of the distal portion 1314 into the opening to non-invasively enlarge it.

[0116] In some embodiments, including a wider puncture member 1310 at the proximal portion of the blade edge 1320 can reduce or prevent contact between the blade edge 1320 and the wall of the delivery catheter lumen. For example, the lateral surfaces 1326, 1328 can contact the wall, thereby maintaining the desired space between the wall and the sharp blade edge 1320.

[0117] refer to Figure 14CThe proximal portion 1312 may include a portion having a uniform or substantially uniform height. In some embodiments, the cross-section of the proximal portion 1312 taken along a plane perpendicular to or substantially perpendicular to the top surface 1322 or the bottom surface 1324 may include a rectangular shape. For example, the cross-section of the proximal portion 1312 taken along a plane extending in a direction extending from the proximal end 1316 toward the distal portion 1314 may include a rectangular shape. The distal portion 1314 may have a height that decreases in a direction extending from the proximal portion 1312 toward the distal edge 1318. For example, the cross-section of the distal portion 1314 taken along a plane extending in a direction extending from the proximal portion 1312 toward the distal edge 1318 may include a triangular shape.

[0118] Figure 15 This is a perspective view of another example of a puncture needle 1400, which includes a puncture member 1410 having a blade edge 1420. The puncture needle 1400 may have outwardly arcuate and / or curved transverse surfaces 1426, 1428. Other features of the puncture needle 1400 may be referenced in the reference. Figure 13 The features are the same as or similar to those of the puncture needle 1300 described in FIG. 14. For example, the puncture member 1410 may include a rounded paddle shape, wherein the blade edge 1420 is on at least a portion of the rounded distal edge of the paddle, and wherein the lateral surfaces 1426, 1428 of the puncture member 1410 include one or more curvatures. The puncture member 1410 may have a top flat or substantially flat surface 1422 and a bottom flat or substantially flat surface 1424, which converge along their respective distal edges to form a distal edge 1418. The blade edge 1420 may be on the distal edge 1418. The blade edge 1420 may extend along the entire or substantially the entire distal edge 1418, or may extend only along a portion of the distal edge 1418. The lateral surfaces 1426, 1428 may extend between the top surface 1422 and the bottom surface 1424.

[0119] The width of the puncture member 1410 may be a dimension extending between opposing portions of the transverse surfaces 1426, 1428, i.e., between a portion of transverse surface 1426 and a portion of transverse surface 1428 opposite to said portion of transverse surface 1426. The height of the puncture member 1410 may be a dimension extending between opposing portions of the top surface 1422 and the bottom surface 1424 (e.g., perpendicular or substantially perpendicular to the longitudinal axis of the puncture needle 1400). The width may be perpendicular or substantially perpendicular to both the height and the longitudinal axis of the puncture needle 1400.

[0120] In some embodiments, the top surface 1422 and the bottom surface 1424 may be flat. In some embodiments, the top surface 1422 and the bottom surface 1424 are parallel or substantially parallel to each other. A cross-section of the proximal portion 1412 taken along a plane parallel or substantially parallel to the top surface 1422 or the bottom surface 1424 may include a trapezoidal shape. For example, a cross-section of the proximal portion 1412 taken along a plane parallel or substantially parallel to the top surface 1422 or the bottom surface 1424 and including opposing portions of the transverse surfaces 1426, 1428 may include a trapezoidal shape. The width of the proximal portion 1412 may increase along a direction extending from the proximal end 1416 toward the distal portion 1414. A cross-section of the distal portion 1414 taken along the same plane may include a semicircle, with the blade edge 1420 on at least a portion of the semicircle. The blade edge 1420 may be a convex, curved blade edge. The proximal portion 1412 may include a portion having a uniform or substantially uniform height. For example, the cross-section of the proximal portion 1412 along the opposing portions including the top surface 1426 and the bottom surface 1428, and along a plane extending in a direction from the proximal end 1416 to the distal portion 1414, may include a rectangular shape. The distal portion 1414 may have a height that decreases along a direction extending from the proximal portion 1412 to the distal edge 1418. For example, the cross-section of the distal portion 1414 along the opposing portions including the top surface 1422 and the bottom surface 1424, and along a plane extending in a direction from the proximal end 1416 to the distal portion 1414, may include a triangular shape.

[0121] As described herein, the transverse surfaces 1426, 1428 may be outwardly arcuate and / or curved. Each of the transverse surfaces 1426, 1428 may include one or more convex curvatures along a direction extending between the top surface 1422 and the bottom surface 1424 (e.g., perpendicular or substantially perpendicular to the top surface 1422 and the bottom surface 1424). For example, the transverse surfaces 1426, 1428 may be rounded. Rounded transverse surfaces 1426, 1428 may facilitate the insertion and / or retraction of the puncture needle 1400 through the delivery catheter lumen. The one or more curvatures may reduce friction between the puncture member 1410 and the wall of the delivery catheter lumen. In some embodiments, the rounded transverse surfaces 1426, 1428 may facilitate the insertion of the puncture member 1410 into a tissue opening formed using the blade edge 1420 to provide non-invasive enlargement of the opening.

[0122] Figures 16 to 23 It is a top-down plan view of other instances including puncture components at the blade edge. Figures 16 to 19 It is a top-down plan view of some instances of puncture components or portions thereof, including the curved blade edges. Figures 16 to 19The puncture components 1500, 1600, 1700, and 1800 shown may each have a respective blade edge 1508, 1608, 1708, and 1808 including a curve. Each of the puncture components 1500, 1600, 1700, and 1800 may have a respective proximal end 1502, 1602, 1702, and 1802, and a respective distal edge 1504, 1604, 1704, and 1804. In some embodiments, the puncture components 1500, 1600, 1700, and 1800 shown may only be portions of the puncture component; for example, the respective proximal ends 1502, 1602, 1702, and 1802 may be coupled to an intermediate member, which in turn is coupled to an elongated portion of the puncture needle. Each of the distal edges 1504, 1604, 1704, and 1804 may include a curved portion, such as a convex curvature. The curvature can have a uniform or non-uniform radius of curvature. For example, each of the distal edges 1504, 1604, 1704, and 1804 can be a convex curved edge, including a convex curved edge containing circular and / or elliptical segments. Blade edges 1508, 1608, 1708, and 1808 can be on their respective distal edges 1504, 1604, 1704, and 1804. For example, each of the blade edges 1508, 1608, 1708, and 1808 can be a convex curved blade edge, including a blade edge with circular and / or elliptical segments. In some embodiments, blade edges 1508, 1608, 1708, and 1808 can extend integrally along their respective distal edges 1504, 1604, 1704, and 1804. In some embodiments, the blade edges 1508, 1608, 1708, 1808 may extend only along a portion of the corresponding distal edges 1504, 1604, 1704, 1804. For example, portions of the distal edges 1504, 1604, 1704, 1804 may be blunt.

[0123] The width of the puncture member may increase, decrease, or remain the same or substantially the same along the direction extending from the proximal end to the distal edge. Each of the puncture members 1500, 1600, 1700, and 1800 may have a respective pair of sides 1506, 1606, 1706, and 1806 extending between the corresponding proximal ends 1502, 1602, 1702, and 1802 and the distal edges 1504, 1604, 1704, and 1804. The width may be a dimension extending between opposing portions of the sides 1506, 1606, 1706, and 1806. The width of the puncture member 1500 may decrease along the direction extending from the distal edge 1504 to the proximal end 1502. The width of the puncture member 1600 may remain at least partially the same or substantially the same along the dimension extending from the proximal end 1602 to the distal edge 1604. The widths of the puncture components 1700 and 1800 may increase in a direction extending from their respective distal edges 1704 and 1804 toward their respective proximal ends 1702 and 1802. In some embodiments, the increased width along the direction extending from their respective distal edges 1704 and 1804 toward their respective proximal ends 1702 and 1802 may facilitate the use of the puncture components 1700 and 1800 as dilators to enlarge the opening formed at the target tissue site.

[0124] refer to Figure 16 , Figure 17 and Figure 18 Sides 1506, 1606, and 1706 may include linear or substantially linear portions. (See reference) Figure 19 The opposing side 1806, extending between the proximal end 1802 and the distal edge 1804 of the puncture member 1800, may include curvature. For example, the opposing side 1806 may include convex curvature. Figure 16 As shown, in some embodiments, the side edge 1506 of the puncture member 1500 may meet the distal edge 1504 at a rounded corner 1510. The rounded corner 1510 may facilitate insertion of the puncture member 1500 through the delivery catheter lumen. (Reference) Figure 17 The distal edge 1604 may include a circular (e.g., semi-circular) segment. For example, blade edge 1608 may include a semi-circular segment. (See reference) Figure 18 and Figure 19 The distal edges 1704 and 1804 of the puncture components 1700 and 1800 may include elliptical segments. For example, the blade edges 1708 and 1808 may each include elliptical segments.

[0125] Figures 20 to 23 It is a top-down plan view of some examples of piercing components with blade edges, the blade edges comprising linear or substantially linear portions between relative curvatures (such as between relative rounded angles). Figures 20 to 23The puncture components 1900, 2000, 2100, and 2200 shown may each include a respective linear or substantially linear blade edge 1908, 2008, 2108, and 2208. Each of the puncture components 1900, 2000, 2100, and 2200 may have a respective proximal end 1902, 2002, 2102, and 2202, and a respective distal edge 1904, 2004, 2104, and 2204. Each of the distal edges 1904, 2004, 2104, and 2204 may include a linear or substantially linear portion. For example, each of the distal edges 1904, 2004, 2104, and 2204 may be a linear or substantially linear edge. The blade edges 1908, 2008, 2108, and 2208 may each be located on their respective distal edges 1904, 2004, 2104, and 2204. For example, each of the blade edges 1908, 2008, 2108, and 2208 may be a linear or substantially linear blade edge. In some embodiments, the blade edges 1908, 2008, 2108, and 2208 may extend integrally along their respective distal edges 1904, 2004, 2104, and 2204, which are blade edges 1908, 2008, 2108, and 2208.

[0126] Each of the puncture components 1900, 2000, 2100, and 2200 may have a pair of respective side edges 1906, 2006, 2106, and 2206 extending between its respective proximal end 1902, 2002, 2102, and its respective distal edge 1904, 2004, 2104, and 2204. (Reference) Figure 20 , Figure 22 and Figure 23 The sides 1906, 2106, and 2206 of the puncture components 1900, 2000, and 2100 may each include linear or substantially linear portions. (See reference) Figure 21 The opposite side 2006 of the puncture member 2000 extending between the proximal end 2002 and the distal edge 2004 may include curvature. For example, the opposite side 2006 may include convex curvature.

[0127] Each pair of paired side edges 1906, 2006, 2106, 2206 may meet with its respective distal edge 1904, 2004, 2104, 2204 at rounded angles 1910, 2010, 2110, 2210. In some embodiments, rounded angles 1910, 2010, 2110, 2210 may be part of leaf edges 1908, 2008, 2108, 2208. Rounded angles 1910, 2010, 2110, 2210 may be sharp to facilitate tissue puncture at the target site. In some embodiments, the rounded corners 1910, 2010, 2110, 2210 can facilitate the insertion of the puncture components 1900, 2000, 2100, 2200 through the delivery catheter lumen, such that if contact occurs between the puncture components 1900, 2000, 2100, 2200, they can slide along the wall of the delivery catheter lumen.

[0128] The width of the puncture member, including linear or substantially linear blade edges, may increase, decrease, or remain the same or substantially the same along the direction extending from the distal edge to the proximal end. The width may be a dimension extending between opposite portions of the side edges 1906, 2006, 2106, and 2206. Figure 20 and Figure 21 The width of the puncture components 1900 and 2000 may be reduced at least partially along the dimension extending from the distal edge 1604 to the proximal end 1602. Figure 23 The width of the puncture component 2200 may be the same or substantially the same along the direction extending from the distal edge 2204 to the proximal end 2202. Figure 22 The width of the puncture member 2100 may increase along the direction extending from the distal edge 2104 toward the proximal end 2102. In some embodiments, the increase in width along the direction extending from the distal edge 2104 toward the proximal end 2102 may facilitate the use of the puncture member 2100 as a dilator to enlarge the opening formed at the target tissue site.

[0129] Figure 24 and Figure 25 These are longitudinal cross-sectional views of examples of puncture components 2300 and 2400, respectively. Puncture components 2300 and 2400 may include respective proximal ends 2302 and 2402 and respective distal ends 2304 and 2404. Two opposing surfaces may extend between these ends. For example, a first top surface 2306 and a first bottom surface 2308 may extend between the proximal end 2302 and the distal end 2304. A second top surface 2406 and a second bottom surface 2408 may extend between the proximal end 2402 and the distal end 2404.

[0130] The top surfaces 2306, 2406 and the bottom surfaces 2308, 2408 may meet along their respective distal edges, including the distal ends 2304, 2404. The blade edges of the piercing members 2300, 2400 may be part of the distal edges. For example, the blade edges may extend into and / or out of the display. Figure 23 and Figure 24 The page.

[0131] The top surfaces 2306, 2406 and the bottom surfaces 2308, 2408 may have one or more opposing portions that are inclined toward each other. (Reference) Figure 23 The first top surface 2306 may include a proximal portion 2310, which is parallel or substantially parallel to the opposing portion of the first bottom surface 2308, such as the proximal portion 2314 of the first bottom surface 2308. The first top surface 2306 may include a first top distal portion 2312, and the first bottom surface 2308 may include a first bottom distal portion 2316. The first top distal portion 2312 and the first bottom distal portion 2316 may be inclined toward each other in a direction extending from the first proximal end 2302 to the first distal end 2304. The first top distal portion 2312 and the first bottom distal portion 2316 may be inclined toward each other and meet at the first distal end 2304. The slope of the first top distal portion 2312 may be the same as or different from the slope of the first bottom distal portion 2316. For example, the first top distal portion 2312 and the first bottom distal portion 2316 may be inclined toward each other to form a distal edge including the blade edge of the puncture member 2300. The slope of the first top distal portion 2312 may be the same as or different from the slope of the first bottom distal portion 2316.

[0132] refer to Figure 25The second top surface 2406 may include a second top proximal portion 2410, which is parallel or substantially parallel to opposing portions of the second bottom surface 2408, such as the second bottom proximal portion 2416. The second top surface 2406 may include a second top central portion 2412 and a second top distal portion 2414. The second bottom surface 2408 may include a second bottom central portion 2418 and a second bottom distal portion 2420. The second top central portion 2412 and the second bottom central portion 2418 may be inclined toward each other in a direction extending from the second proximal end 2402 to the second distal end 2404. The slope of the second top central portion 2412 may be the same as or different from the slope of the second bottom central portion 2414. The second top distal portion 2414 and the second bottom distal portion 2418 may be inclined toward each other in a direction extending from the second proximal end 2402 to the second distal end 2404. The second top distal portion 2414 and the second bottom distal portion 2418 may be inclined toward each other and meet at the second distal end 2404. For example, the second top distal portion 2414 and the second bottom distal portion 2418 may be inclined toward each other to form a distal edge including the blade edge of the puncture member 2400. The slope of the second top distal portion 2416 may be the same as or different from the slope of the second bottom distal portion 2418. The slope of the second top central portion 2412 may be different from the slope of the second top distal portion 2414. The slope of the second bottom central portion 2418 may be different from the slope of the second bottom distal portion 2420.

[0133] As described herein, in some embodiments, one or more portions of the puncture member may be inserted into a tissue opening to enlarge the opening formed in said tissue. For example, the height, width, and / or taper of one or both of the puncture members 2300, 2400 may be selected based on the desired enlargement of the opening. The height may be a dimension extending between a portion of the top surface 2306, 2406 and a portion of the respective bottom surface 2308, 2408 opposite said portion of the top surface 2306, 2406. The width may be a dimension perpendicular to or substantially perpendicular to the height (e.g., extending into and / or out of the page).

[0134] In some embodiments, the top surfaces 2306, 2406 and the bottom surfaces 2308, 2408 may be flat or substantially flat. In some embodiments, the top surfaces 2306, 2406 and the bottom surfaces 2308, 2408 may include one or more curvatures, including convex curvatures. For example, the puncture members 2300, 2400 may include a generally tapered shape.

[0135] Figure 26This is a process flow diagram of an example of a procedure 2600 for deploying a puncture needle, the puncture needle including a puncture component having a blade-like edge as described herein. In block 2602, procedure 2600 relates to inserting the puncture needle into the lumen of a delivery catheter. The puncture needle may include a puncture component having a blade-like edge configured to puncture tissue. The blade-like edge may have any of the configurations described herein. In some embodiments, the blade-like edge may be a convex, curved blade-like edge. In some embodiments, the blade-like edge may include a linear or substantially linear blade-like edge between opposing curve angles.

[0136] In block 2604, process 2600 involves advancing a puncture needle through a bend in the delivery catheter lumen. The puncture member can be advanced through the bend without becoming stuck against the wall of the delivery catheter lumen. For example, a blade edge can facilitate sliding of the puncture member along the wall of the delivery catheter lumen. In some embodiments, the width of the portion of the puncture member proximal to the blade edge can be wider than the width of the blade edge to facilitate maintaining a desired space between the blade edge and the wall of the delivery catheter lumen, thereby reducing or avoiding contact between the blade edge and the wall.

[0137] In block 2606, process 2600 involves extending a puncture component through the outlet opening of a delivery catheter. The puncture component can be deployed after the puncture needle has been advanced to the desired location. In block 2608, process 2600 involves puncturing tissue at a target tissue site using the edge of a blade to create an opening in said tissue. As described herein, the target tissue site can be any number of internal blood vessels, channels, organs, and / or chambers. In some embodiments, the target site can be on the left atrial wall. In some embodiments, the puncture needle can be positioned within the coronary sinus to allow access to the left atrial wall from within the coronary sinus. For example, the delivery catheter can be positioned from the right atrium via the coronary sinus ostium into the coronary sinus using a transfemoral approach. The puncture needle can then be deployed from the lumen of the delivery catheter to create an opening in the left atrial wall from within the coronary sinus. In some embodiments, a transclavian or transjugular approach can be used.

[0138] In some embodiments, after the opening is formed, a puncture member, including the leaf edge, may optionally be further inserted into the opening to enlarge it. As described herein, the size and / or shape of the puncture member can be selected based on the desired enlargement of the opening formed in the tissue. For example, the width of the puncture member may increase along a direction extending from the leaf edge toward the proximal portion of the puncture member to facilitate opening enlargement. As described herein, a puncture member, for example, comprising a rounded shape, can be used to achieve gradual enlargement. Since one or more blunt portions of the puncture member can be used to perform enlargement, non-invasive incremental enlargement can also be achieved.

[0139] Other implementation methods

[0140] Depending on the implementation, certain actions, events, or functions in any process or algorithm described herein may be performed in a different order, added, combined, or omitted entirely. Therefore, in some implementations, not all described actions or events are necessary for the practice of the process.

[0141] Unless otherwise specifically stated or understood in the context in which they are used, conditional language used herein, such as “can,” “may,” “possibly,” “can,” “e.g.,” is intended to be used in its ordinary sense and is generally intended to convey that certain embodiments include certain features, elements, and / or steps that are not included in other embodiments. Therefore, such conditional language is not generally intended to imply that a feature, element, and / or step is necessary in any way for one or more embodiments, or that one or more embodiments must include logic for determining (with or without author input or prompting) whether such features, elements, and / or steps are included or will be performed in any particular embodiment. The terms “comprising,” “including,” “having,” etc., are synonymous, used in their ordinary sense, and used inclusively in an open-ended manner, without excluding additional elements, features, actions, operations, etc. Furthermore, the term “or” is used in its inclusive sense (rather than in its exclusive sense) such that, when used, for example, in conjunction with an enumeration of elements, the term “or” means one, some, or all of the enumerated elements. Unless otherwise specifically stated, connective language such as the phrase "at least one of X, Y, and Z" should be understood in the context in which it is used to generally convey that an item, term, element, etc., can be any one of X, Y, or Z. Therefore, such connective language is generally not intended to imply that some implementation requires at least one of X, at least one of Y, and at least one of Z to be present.

[0142] It should be understood that in the above description of the embodiments, various features are sometimes combined in a single embodiment, drawing, or description thereof to simplify this disclosure and aid in understanding one or more aspects of the invention. However, this method of disclosure should not be construed as reflecting an intention that any claim requires more features than those expressly recited in that claim. Furthermore, any component, feature, or step exemplified and / or described in the specific embodiments herein may be applied to or used with any other embodiment(s). Further, for each embodiment, no component, feature, step, or group of components, features, or steps is necessary or indispensable. Therefore, the scope of the invention intended to be disclosed herein and claimed below should not be limited by the specific embodiments described above, but should be determined solely by a fair reading of the appended claims.

[0143] It should be understood that certain ordinal terms (e.g., “first” or “second”) may be provided for ease of reference and do not necessarily imply physical characteristics or order. Therefore, as used herein, ordinal terms used to modify elements such as structure, component, operation, etc. (e.g., “first,” “second,” “third,” etc.) do not necessarily indicate the priority or order of that element relative to any other element, but rather generally distinguish that element from another element with a similar or identical name (if ordinal terms were not used). Furthermore, as used herein, indefinite articles (“a” and “a / kind”) can mean “one (kind) or more (kinds)” rather than “one (kind).” Moreover, an operation performed “based on” a certain condition or event can also be performed based on one or more other conditions or events that are not explicitly stated.

[0144] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by one of ordinary skill in the art to which the exemplary embodiments pertain. It should be further understood that terms, as defined in common dictionaries, should be interpreted as having meanings consistent with their meanings in the context of the relevant field, and should not be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0145] The spatially relative terms “outside,” “inside,” “above,” “below,” “below,” “above,” “vertical,” “horizontal,” and similar terms may be used herein for ease of description to describe the relationship between one element or component and another element or component exemplified in the accompanying drawings. It will be understood that, in addition to the orientations depicted in the drawings, the spatially relative terms are intended to cover different orientations of the device during use or operation. For example, in the case where the device shown in the drawings is flipped, a device positioned “below another device” or “under another device” may be placed “above another device.” Thus, the exemplary term “below” can include both a below position and an above position. The device may also be oriented in another direction, and therefore the spatially relative terms may be interpreted differently depending on the orientation.

[0146] Unless otherwise explicitly stated, comparative and / or quantitative terms such as “less,” “more,” and “greater” are intended to encompass the concept of equality. For example, “less” can mean not only “less” in the strictest mathematical sense, but also “less than or equal to.”

Claims

1. Puncture system, including: A puncture needle configured to be slidably advanced through a delivery catheter lumen, the puncture needle comprising: The slender part; and A puncture component, associated with the distal end of the elongated portion, configured to puncture tissue; and A spacer, the spacer being associated with the distal portion of the elongated portion; The spacer is configured to contact the wall of the delivery catheter lumen to prevent contact between the puncture component and the wall as the puncture component is advanced through a bend in the delivery catheter lumen. The spacer is integrally formed with or configured to couple to the puncture needle, and The spacer has a width that is at least partially predetermined based on the distance between the spacer and the distal end of the puncture member, to prevent contact between the distal end of the puncture member and the wall of the delivery catheter lumen.

2. The system of claim 1, wherein the spacer includes a predetermined lateral dimension and a predetermined longitudinal dimension, the predetermined lateral dimension and the predetermined longitudinal dimension being configured to prevent contact between the distal end of the puncture member and the wall.

3. The system of claim 1 or 2, wherein the spacer includes a distal end, a proximal end, and a transverse surface between the distal end and the proximal end, wherein the transverse surface is spaced a predetermined transverse distance from the distal portion of the elongated portion, and at least one of the transverse surface and the distal end is configured to contact the wall of the delivery catheter lumen to prevent contact between the distal end of the puncture member and the wall.

4. The system of claim 3, wherein the lateral surface comprises a concave, curved surface configured to contact the wall of the delivery catheter lumen.

5. The system of claim 3, wherein the lateral surface comprises a convex, curved surface configured to contact the wall of the delivery catheter lumen.

6. The system of claim 3, wherein the transverse surface comprises a surface parallel to the longitudinal axis of the puncture needle and configured to contact the wall of the delivery catheter lumen.

7. The system according to claim 1 or 2, wherein the longitudinal cross-section of the spacer includes at least one of a circular segment, an elliptical segment, and a teardrop-shaped segment, wherein the plane along which the longitudinal cross-section extends laterally from the distal portion of the elongated portion along the longitudinal axis of the puncture needle.

8. The system according to any one of claims 1 to 2 and 4 to 6, wherein the spacer is symmetrical about an axis collinear with the longitudinal axis of the puncture needle.

9. The system according to any one of claims 1 to 2 and 4 to 6, wherein the spacer is asymmetrical about an axis collinear with the longitudinal axis of the puncture needle.

10. The system of claim 9, wherein the spacer extends circumferentially around the distal portion of the elongated portion.

11. The system of claim 9, wherein the spacer is circumferentially positioned around the distal portion of the elongated portion.

12. The system of claim 11, wherein the spacer comprises an annular element.

13. The system of claim 12, wherein the annular transverse surface includes a concave curvature.

14. The system of claim 12, wherein the annular transverse surface includes a convex curvature.

15. The system of claim 12, wherein the transverse surface of the annulus is parallel to an axis collinear with the longitudinal axis of the puncture needle.

16. The system according to any one of claims 1 to 2, 4 to 6 and 10 to 11, wherein the spacer comprises a plurality of different portions positioned around the distal portion of the elongated portion.

17. The system of claim 16, wherein the spacer comprises a plurality of lobes positioned circumferentially around the distal portion.

18. The system of claim 16, wherein the spacer comprises a plurality of plates extending circumferentially around the distal portion of the elongated portion.

19. The system according to any one of claims 1 to 2, 4 to 6, 10 to 15 and 17 to 18, wherein the spacer is adjacent to the puncture member.

20. The system according to any one of claims 1 to 2, 4 to 6, 10 to 15 and 17 to 18, wherein the spacer is located at a predetermined distance proximal to the puncture member.

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